Australian court says genes can be patented

Patents on breast-cancer gene challenged in US fare better in Australia.

A major legal battle is underway over gene patents in the US and is now headed to the Supreme Court, with oral arguments scheduled for April. A similar battle is taking place in Australia, and proponents of gene patents have just won a major victory in that nation.

An Australian federal judge has ruled that because the BRCA1 cancer gene has been "isolated" from the human body, it's appropriate to grant a patent on it. "The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated," wrote the judge.

That's the exact opposite of the finding by the judge who heard the US case, who agreed with various doctors' groups and the ACLU that the whole idea of "isolating" genes really doesn't change the calculus. The patent holder was effectively demanding a monopoly on any doctors who viewed the gene, and that was unacceptable. The genetics company lost at district court, won at the patent-friendly US Court of Appeals for the Federal Circuit, and now has its caseheaded to the US Supreme Court.

The patent-holder in the case is the same one that claims to own the BRCA1 gene in the US, Utah-based Myriad Genetics. (Hat tip to Techdirt.) The case was brought by an Australian advocacy group, Cancer Voices Australia. Today's Australian ruling could be appealed to a three-judge panel, which would have the final say unless the case went to the High Court of Australia, the equivalent of the US Supreme Court.

The BRCA1 and BRCA2 genes are important because they can predict a woman's likelihood of contracting breast or ovarian cancer. In the US, the Myriad test can cost upwards of $3,000 and isn't always covered by insurance. In Canada, where Myriad has threatened but failed to enforce its patent, doctors have been able to offer test results for one-third of the US cost, and get results far quicker.

The politics of these gene patents in Australia differ from the US. One reason the ACLU targeted Myriad in the US was because of Myriad's vigorous enforcement efforts. The company sent cease-and-desist letters to researchers and threatened lawsuits. In Australia, Myriad outsourced its patent to a Melbourne company, which "gifted" the patent rights to many health care institutions and promised not to demand royalties for testing.

I'm surprised these jerks are only trying for patentabilty of genes since in most places patents only last like 20 years. If they tried to copyright gene sequences they could sue people for much longer.

If they'd patented a specific mechanism for testing for the relevant gene, I'd probably have more sympathy. (Although I can't see a way to make a mechanism that tests for just a single gene; I'm also not a geneticist.)

But I can't see patenting the gene itself. It strikes me as not markedly different (except in physical scale) to taking out a patent on removing a rose petal and examining to ensure that the flower is, in fact, a rose. Then enforcing that patent every time someone grows or presents a rose, scatters rose petals, etc.

I have run into something similar to this with a medical condition I have. I have a weird presentation of an autoimmune disease where my immune system attacks my saliva glands. It has required me to see an out of state specialist in California who is a national specialist on this and related diseases. He wanted to run a test to see if I had some specific genes, but they have been patented in the US. Basically the company that holds the patent is being a PITA about testing for it in the US and if they allow it then they charge large amounts of money, so he has been considering sending me to France where they don't have a patent and a research hospital there can test for it.

Generally, the justification for patenting an isolated DNA sequence is that an isolated DNA gene sequence is not naturally found in nature. DNA in the cell in is bound up with proteins and contained in large sequence. One has to perform a series of steps in order to obtain it: e.g., lyse the cell, extract the DNA, cleave out particular sequence using specific restriction enzymes, (many human genes contain crap sequences as well which need to be excised), purify it, etc.. The isolated DNA is thus obtained via human actions--made by people.

The judge in US case argued it was akin to pulling a leaf off a tree and said argued that it is natural/can't patent. Not great analogy but case is under appeal so it'll take some time to get final answer.

If they were to modify the gene to do something novel, then that would be patentable. But not the gene exactly as it exists in nature.

What makes you think that they didn't? The HGP reported that there were 23 genes per million base pairs on chromosome 19 (for a total of 1,400 genes), down to as little as 5 genes per million base pairs on other chromosomes. Isolating the BRCA genes from all of that DNA polymer creates something that does not exist in nature -- just like isolating the PCR process from all the other materials found in cells created a process that does not occur in nature.

In addition, the US judge threw out claims to to cDNA fragments since what the judge deemed "important" was the information contained in both the gene and the cDNA, not the molecule itself. The problem with that is that the cDNA molecule is a sensor for the presence of the DNA, and can be used in a microarray as a diagnostic for the presence of the gene. So even when changed to do something arguably novel (sense the presence of the gene) in the form of a non-natural molecule which represents only a fragment of the gene, the cDNA is unpatentable.

The only way that you get to "as it exists in nature" is to do the tortured dance that the district court judge did -- ignore the actual structure of the matter involved and 'find' that the patent seeks to patent mere information, "the gene," after simply separating it from the genome and "tinkering" with its form. The key problem in the higher courts is going to be the long history of law allowing anyone to patent new molecules, and the fact that the isolated DNA, cDNA, mRNA, etc., particularly when pared down to a fragment useful for diagnostic testing, is quite clearly a molecule.

District court creativity does not tend to survive at the appellate level. Not to say that it cannot happen, but it's pretty darn unlikely.

If the gene hadn't been isolated before, why don't they patent the means of isolating it, or the test they're apparently charging $3K for? Either of those options seem like reasonably accommodated options under current patent standards.

If they were to modify the gene to do something novel, then that would be patentable. But not the gene exactly as it exists in nature.

What makes you think that they didn't? The HGP reported that there were 23 genes per million base pairs on chromosome 19 (for a total of 1,400 genes), down to as little as 5 genes per million base pairs on other chromosomes. Isolating the BRCA genes from all of that DNA polymer creates something that does not exist in nature -- just like isolating the PCR process from all the other materials found in cells created a process that does not occur in nature.

That is obviously wrong: The reason for interest in the BRCA gene is that, if a woman has it, it predicts the likelihood of her getting cancer. Clearly "a woman has it" implies that it occurs in nature. Logic 101.

The fact that it takes a lot of effort to do something does not imply that the result must be patentable.

If the gene hadn't been isolated before, why don't they patent the means of isolating it, or the test they're apparently charging $3K for? Either of those options seem like reasonably accommodated options under current patent standards.

Because methods of obtaining said genes are standard. You normally just switch a couple things around to make it specific, but its hardly a novel invention.

DRJlaw wrote:

What makes you think that they didn't? What makes you think that they didn't? The HGP reported that there were 23 genes per million base pairs on chromosome 19 (for a total of 1,400 genes), down to as little as 5 genes per million base pairs on other chromosomes. Isolating the BRCA genes from all of that DNA polymer creates something that does not exist in nature -- just like isolating the PCR process from all the other materials found in cells created a process that does not occur in nature.

They aren't patenting PCR, they are patenting the gene sequence and all uses of the gene sequence. At this point, isolating any arbitrary sequence out of DNA is standard practice. There is nothing novel or unique about any particular part of the genome, and anyone in the field can do so for any sequence they choose. If the DNA molecule were doing anything other than acting as an information carrier, there might be an argument, but it is not.

DRJlaw wrote:

In addition, the US judge threw out claims to to cDNA fragments since what the judge deemed "important" was the information contained in both the gene and the cDNA, not the molecule itself. The problem with that is that the cDNA molecule is a sensor for the presence of the DNA, and can be used in a microarray as a diagnostic for the presence of the gene. So even when changed to do something arguably novel (sense the presence of the gene) in the form of a non-natural molecule which represents only a fragment of the gene, the cDNA is unpatentable.

Again, this is standard practice that can be done for any arbitrary sequence. Now, if they developed a specific segment of the cDNA that was optimal, I could see an argument for those specific details to be patented. But they would have had to do something above and beyond--and even in that case, it is the ASSAY which could be patented, not the gene.

DRJlaw wrote:

The key problem in the higher courts is going to be the long history of law allowing anyone to patent new molecules, and the fact that the isolated DNA, cDNA, mRNA, etc., particularly when pared down to a fragment useful for diagnostic testing, is quite clearly a molecule.

If that's true, then the law doesn't reflect how biology works, let alone polymers.

Doesn't having extracted the sample prove there was prior art? Should we be giving patents to Mother Earth now?

Joking aside, I'd hope that ethical concerns from the medical community would cause this to go down in flames. Patenting how you figured out the method of extracting it? Sure. Still don't like the idea, but livable. Patenting a piece of nature that could help save people's lives? The English language doesn't contain enough obscenities that need to be placed before the word "No".

If they were to modify the gene to do something novel, then that would be patentable. But not the gene exactly as it exists in nature.

What makes you think that they didn't? The HGP reported that there were 23 genes per million base pairs on chromosome 19 (for a total of 1,400 genes), down to as little as 5 genes per million base pairs on other chromosomes. Isolating the BRCA genes from all of that DNA polymer creates something that does not exist in nature -- just like isolating the PCR process from all the other materials found in cells created a process that does not occur in nature.

That is obviously wrong: The reason for interest in the BRCA gene is that, if a woman has it, it predicts the likelihood of her getting cancer. Clearly "a woman has it" implies that it occurs in nature. Logic 101.

The fact that it takes a lot of effort to do something does not imply that the result must be patentable.

You're going to have to explain the "obviously" in "obviously wrong," since it's the basis of the Australian ruling as well as the US Court of Appeals ruling that is being appealed to the US Supreme Court.

In sum, although the parties and the government ap-pear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. As set forth below, we conclude that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101.

Quote:

It is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form—as distinctive chemi-cal molecules—from DNAs in the human body, i.e., native DNA. Natural DNA exists in the body as one of forty-six large, contiguous DNA molecules. Each of those DNA molecules is condensed and intertwined with various proteins, including histones, to form a complex tertiary structure known as chromatin that makes up a larger structural complex, a chromosome. See supra, Figure 3. Inside living cells, the chromosomes are further encapsu-lated within a series of membranes and suspended in a complex intracellular milieu.

Quote:

[I]solated DNA molecules do not exist in nature within a physical mixture to be purified. They have to be chemi-cally cleaved from their native chemical combination with other genetic materials. In other words, in nature, the claimed isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity that is obtained by human intervention. See Chakrabarty, 447 U.S. at 313 (“the relevant distinction [is] between products of nature . . . and human-made inventions”). In fact, some forms of isolated DNA may require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

The reason for interest is irrelevant. The molecule did not exist in the claimed form prior to Myriad's research. Otherwise we'd be arguing lack of novelty or nonobviousness, not "product of nature."

...Now, if they developed a specific segment of the cDNA that was optimal, I could see an argument for those specific details to be patented...

This makes sense. If someone would develop a novel genetic sequence, which gives advantage to an organism after being introduced to it, then that's clearly intellectual property and should be protected as such.

What makes you think that they didn't? What makes you think that they didn't? The HGP reported that there were 23 genes per million base pairs on chromosome 19 (for a total of 1,400 genes), down to as little as 5 genes per million base pairs on other chromosomes. Isolating the BRCA genes from all of that DNA polymer creates something that does not exist in nature -- just like isolating the PCR process from all the other materials found in cells created a process that does not occur in nature.

They aren't patenting PCR, they are patenting the gene sequence and all uses of the gene sequence. At this point, isolating any arbitrary sequence out of DNA is standard practice. There is nothing novel or unique about any particular part of the genome, and anyone in the field can do so for any sequence they choose. If the DNA molecule were doing anything other than acting as an information carrier, there might be an argument, but it is not.

(1) I did not argue that they were patenting PCR. (2) "At this point" ignores the fact that these patents are from work conducted almost 20 years ago, and you cannot judge the novelty or obviousness of a patent based upon the technological advances that have been made since. You have to look back to the early 1990s before anyone will begin to take this argument seriously. (3) The cDNA is acting as something other than an information carrier. It is sensing the presence of the gene.

BioTurboNick wrote:

DRJlaw wrote:

In addition, the US judge threw out claims to to cDNA fragments since what the judge deemed "important" was the information contained in both the gene and the cDNA, not the molecule itself. The problem with that is that the cDNA molecule is a sensor for the presence of the DNA, and can be used in a microarray as a diagnostic for the presence of the gene. So even when changed to do something arguably novel (sense the presence of the gene) in the form of a non-natural molecule which represents only a fragment of the gene, the cDNA is unpatentable.

Again, this is standard practice that can be done for any arbitrary sequence. Now, if they developed a specific segment of the cDNA that was optimal, I could see an argument for those specific details to be patented. But they would have had to do something above and beyond--and even in that case, it is the ASSAY which could be patented, not the gene.

But you can't point to the sequence prior to the disclosure made in the patent, can you? There wasn't an HGP project database 20 years ago. You again ignore the fact that these patents are from work conducted almost 20 years ago, and try to judge the novelty or obviousness based upon the results of the HGP.

BioTurboNick wrote:

DRJlaw wrote:

The key problem in the higher courts is going to be the long history of law allowing anyone to patent new molecules, and the fact that the isolated DNA, cDNA, mRNA, etc., particularly when pared down to a fragment useful for diagnostic testing, is quite clearly a molecule.

If that's true, then the law doesn't reflect how biology works, let alone polymers.

Biology doesn't produce these isolated molecules. Biology produces a swamped and polymerized mess. Find a way to produce a test using a mashed up cell, and you won't infringe the patents. Find a way to produce a test using even a purified chomosome and you won't infringe the patent. Sequence a mess of restricted genetic material and you won't infringe the patents. To make something useful, you had to do more than this 20 years ago. To make something useful, you still have to do more than this today, since even genome sequencing exceeds the cost of the cDNA method. Myriad and its partners did that, and appear to have done it first. Now you want to argue that they didn't do anything, and that what they did was "standard." Too bad the courts aren't buying it.

"The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated," wrote the judge.

This is back to the argument for patenting the air or water or titanium or how an eye functions or hearing or tornados or moving at 70 mph.

At least its nice to know that Australian courts are jsut as retarded as others around the world.

TMilligan wrote:

So could they now sue women with breast cancer for infringement like other patent trolls targeting the "end user?"

Yes. Absolutely. Can't wait for this to gain momentum. A woman given 6 months to live with an advanced case of breast cancer gets sued for 50 million dollars for infringing a patented DNA sequence.

Catch is - if her medical records are confidential - how does the patent troll find out ?

Nonapod wrote:

I'm surprised these jerks are only trying for patentabilty of genes since in most places patents only last like 20 years. If they tried to copyright gene sequences they could sue people for much longer.

Copyright wouldn't apply. They would have had to create these sequences from scratch as unique original works. Not isolate a pre-existing pattern.

"The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated," wrote the judge.

This is back to the argument for patenting the air or water or titanium or how an eye functions or hearing or tornados or moving at 70 mph.

At least its nice to know that Australian courts are jsut as retarded as others around the world.

TMilligan wrote:

So could they now sue women with breast cancer for infringement like other patent trolls targeting the "end user?"

Yes. Absolutely. Can't wait for this to gain momentum. A woman given 6 months to live with an advanced case of breast cancer gets sued for 50 million dollars for infringing a patented DNA sequence.

Wow. Just wow. You specifically quote the Australian court's statement that the claims only apply to DNA and RNA which have ben extracted from cells, and immediately turn to assuring others that the claims apply to DNA and RNA which have never been extracted from a cell, and which have not been isolated from anything, and which have no possibility of being worth $50m per person (since the test itself is only $3k). Fear mongering in its lowest, most irrational form. Bravo.

You're going to have to explain the "obviously" in "obviously wrong," since it's the basis of the Australian ruling as well as the US Court of Appeals ruling that is being appealed to the US Supreme Court.

Obviously, that leads to the conclusion that the ruling is wrong.

You seem to confuse facts in the real world with statements that are deemed 'fact' by law. They extracted a small part of human DNA and figured out what it does. Whether that is patentable is a legal question, but the claim that it is something not occurring in nature is patently false. Decoding a message (DNA) is quite different from coming up with a new message.

What makes you think that they didn't? What makes you think that they didn't? The HGP reported that there were 23 genes per million base pairs on chromosome 19 (for a total of 1,400 genes), down to as little as 5 genes per million base pairs on other chromosomes. Isolating the BRCA genes from all of that DNA polymer creates something that does not exist in nature -- just like isolating the PCR process from all the other materials found in cells created a process that does not occur in nature.

They aren't patenting PCR, they are patenting the gene sequence and all uses of the gene sequence. At this point, isolating any arbitrary sequence out of DNA is standard practice. There is nothing novel or unique about any particular part of the genome, and anyone in the field can do so for any sequence they choose. If the DNA molecule were doing anything other than acting as an information carrier, there might be an argument, but it is not.

(1) I did not argue that they were patenting PCR. (2) "At this point" ignores the fact that these patents are from work conducted almost 20 years ago, and you cannot judge the novelty or obviousness of a patent based upon the technological advances that have been made since. You have to look back to the early 1990s before anyone will begin to take this argument seriously. (3) The cDNA is acting as something other than an information carrier. It is sensing the presence of the gene.

BioTurboNick wrote:

DRJlaw wrote:

In addition, the US judge threw out claims to to cDNA fragments since what the judge deemed "important" was the information contained in both the gene and the cDNA, not the molecule itself. The problem with that is that the cDNA molecule is a sensor for the presence of the DNA, and can be used in a microarray as a diagnostic for the presence of the gene. So even when changed to do something arguably novel (sense the presence of the gene) in the form of a non-natural molecule which represents only a fragment of the gene, the cDNA is unpatentable.

Again, this is standard practice that can be done for any arbitrary sequence. Now, if they developed a specific segment of the cDNA that was optimal, I could see an argument for those specific details to be patented. But they would have had to do something above and beyond--and even in that case, it is the ASSAY which could be patented, not the gene.

But you can't point to the sequence prior to the disclosure made in the patent, can you? There wasn't an HGP project database 20 years ago. You again ignore the fact that these patents are from work conducted almost 20 years ago, and try to judge the novelty or obviousness based upon the results of the HGP.

BioTurboNick wrote:

DRJlaw wrote:

The key problem in the higher courts is going to be the long history of law allowing anyone to patent new molecules, and the fact that the isolated DNA, cDNA, mRNA, etc., particularly when pared down to a fragment useful for diagnostic testing, is quite clearly a molecule.

If that's true, then the law doesn't reflect how biology works, let alone polymers.

Biology doesn't produce these isolated molecules. Biology produces a swamped and polymerized mess. Find a way to produce a test using a mashed up cell, and you won't infringe the patents. Find a way to produce a test using even a purified chomosome and you won't infringe the patent. Sequence a mess of restricted genetic material and you won't infringe the patents. To make something useful, you had to do more than this 20 years ago. To make something useful, you still have to do more than this today, since even genome sequencing exceeds the cost of the cDNA method. Myriad and its partners did that, and appear to have done it first. Now you want to argue that they didn't do anything, and that what they did was "standard." Too bad the courts aren't buying it.

I assume you're a lawyer. This sort of playing around with the technicalities of the law is rather annoying and counterproductive to our society.

Biology doesn't produce these isolated molecules. Biology produces a swamped and polymerized mess. Find a way to produce a test using a mashed up cell, and you won't infringe the patents. Find a way to produce a test using even a purified chomosome and you won't infringe the patent. Sequence a mess of restricted genetic material and you won't infringe the patents. To make something useful, you had to do more than this 20 years ago. To make something useful, you still have to do more than this today, since even genome sequencing exceeds the cost of the cDNA method.

Actually it's very much an open question in the US if Myriad will be able to successfully argue full genome sequencing (including looking at BRCA1 and BRCA2) as infringement. We should find out very soon as costs drop below the price Myriad charges for the BRCA test. If they don't file suit, they're quickly going to lose a *major* source of income, so they'll be very motivated to at least try.

However, it's disingenuous at best to suggest that this is as pat a situation as you suggest. Joe didn't mention this (but it is covered in the linked earlier ars coverage), but the Supreme Court has already sent this case back to the federal circuit to be reconsidered in light of their strike down of patents on a large class of medical diagnostic tests.

The leaf analogy isn't great, but there is a subtlety there that you're ignoring:

Judge Bryson wrote:

Prematurely plucking the leaf would not turn it into a human-made invention. That would remain true if there were minor differences between the plucked leaf and the fallen autumn leaf, unless those differences imparted "markedly different characteristics" to the plucked leaf.

While the "leaf" in this case *is* different once removed in that it (probably) doesn't exist in isolation unless specifically plucked, *functionally* any differences are irrelevant since you're only interested in its function as part of the "tree". In other words, the only characteristics of the genes that you're interested in are the ones it already had in situ, so there is no marked difference.

This is, incidentally, more or less the same intuitive argument that most people bring up when they have a problem with these kinds of patents: that the characteristic that makes the gene a bellwether is already present, and Myriad hasn't created that indicator, nor have they created a way of inferring that indication from the result. What they *have* created is a process of isolating the gene that contains that characteristic, and if the process is novel, it very well could be eligible for patent protection (of course, it's not a novel process, which is one of several problems here for Myriad).

This is also what Bryson argued:

Judge Bryson wrote:

Neither isolation of the naturally occurring material nor the resulting breaking of covalent bonds makes the claimed molecules patentable. We have previously stated that “isolation of interesting compounds is a mainstay of the chemist’s art,” and that “[i]f it is known how to perform such an isolation doing so ‘is likely the product not of innovation but of ordinary skill and common sense.’” Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1302 (Fed. Cir. 2007), quoting KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007). Similarly, the structural changes ancillary to the isolation of the gene do not render these claims patentable. The cleaving of covalent bonds incident to isolation is itself not inventive, and the fact that the cleaved molecules have terminal groups that differ from the naturally occurring nucleotide sequences does nothing to add any inventive character to the claimed molecules. The functional portion of the composition—the nucleotide sequence—remains identical to that of the naturally occurring gene.

(emphasis added)

The only thing we can unquestionably grant them is that they isolated the gene first. However then they just have a diagnostic test (uh-oh) for a "naturally occurring article", which is explicitly not patentable.

DRJlaw wrote:

Myriad and its partners did that, and appear to have done it first. Now you want to argue that they didn't do anything, and that what they did was "standard." Too bad the courts aren't buying it.

This part is just incorrect. Go look at the case. This is actually one of the key arguments of the plaintiffs and in the US only the majority of the Federal Circuit "aren't buying" *all* parts of that argument, hinging solely on use of the word "isolated" in the patent claims, while still striking down virtually all of Myriad's diagnostic claims.

This could very well go Myriad's way (though the Supreme Court seems to think that Bilski and Prometheus v. Mayo apply much more here than the federal circuit does), but please stop suggesting that your opinion happens to also be settled law.

As the article says (albeit rather obtusely), this is the trial verdict only. It will be appealed to the Full Federal Court (the "three member panel"), because otherwise it has no particular value as precedent (which helps nobody). Given the nature of the case - it's definitely novel - I would expect it to be given leave to appeal to the High Court if the party unsuccessful on appeal so wishes.

You're going to have to explain the "obviously" in "obviously wrong," since it's the basis of the Australian ruling as well as the US Court of Appeals ruling that is being appealed to the US Supreme Court.

Obviously, that leads to the conclusion that the ruling is wrong.

You seem to confuse facts in the real world with statements that are deemed 'fact' by law. They extracted a small part of human DNA and figured out what it does. Whether that is patentable is a legal question, but the claim that it is something not occurring in nature is patently false. Decoding a message (DNA) is quite different from coming up with a new message.

You seem to disregard facts in the real world that do not agree with your viewpoint. Show me where the claimed molecule exists. Because even the government agrees that it does not exist within a living cell.

They were not decoding any message, or coming up with any new message. They were developing a small molecule which chemically binds to a particular gene. That small molecule does not occur in nature. Merely saying that claims to the contrary are "patently false" does not make it so. Show me where the claimed molecule exists.

I assume you're a lawyer. This sort of playing around with the technicalities of the law is rather annoying and counterproductive to our society.

"Technicalities of the law" such whether that addition to your house complies with the building code, whether the radar gun that clocked you at 63 mph in a 60 mph zone really was calibrated properly or reading 5 mph fast, or whether you actually qualify for social security disability.

It's amazing how standards become "technicalities" when they run counter to your preferred outcome. You draw a line, and then try to retroactively redraw it when something falls on one side in a way that you don't like.

However, it's disingenuous at best to suggest that this is as pat a situation as you suggest. Joe didn't mention this (but it is covered in the linked earlier ars coverage), but the Supreme Court has already sent this case back to the federal circuit to be reconsidered in light of their strike down of patents on a large class of medical diagnostic tests.

Except for the fact that Prometheus dealt with method claims like the methods of diagnosis which the Federal Circuit invalidated, not any product of nature exception. In addition, a GVR does not indicate that the lower court decision was wrong. You're going to have to wait for an opinion concerning the Myriad patents themselves before you can confortably predict a reversal of longstanding USPTO interpretations concerning the patentability of isolated genes and prior cases concerning small molecules.

MrMalthus wrote:

The leaf analogy isn't great, but there is a subtlety there that you're ignoring:

Judge Bryson wrote:

Prematurely plucking the leaf would not turn it into a human-made invention. That would remain true if there were minor differences between the plucked leaf and the fallen autumn leaf, unless those differences imparted "markedly different characteristics" to the plucked leaf.

While the "leaf" in this case *is* different once removed in that it (probably) doesn't exist in isolation unless specifically plucked, *functionally* any differences are irrelevant since you're only interested in its function as part of the "tree". In other words, the only characteristics of the genes that you're interested in are the ones it already had in situ, so there is no marked difference.

Judge Bryson's leaf analogy is a flawed analogy at best. The isolated DNA is "markedly different" from the whole DNA in the first instance because the extraneous DNA has been removed -- just as a cut diamond is markedly different from a raw diamond. Biologists could certainly explain the advantage of this form better than I. The isolated cDNA is more clearly "markedy different" because it will preferentially bind the BRCA gene. Smaller, non-unique cDNAs would bind to other genes, other portions of the DNA, etc. losing the ability to serve as a selective sensor. Larger 'whole' cDNAs would, if they bound any DNA at all, bind to adjacent genes, portions of non-gene DNA, etc., again losing selectivity. If you pluck a new leaf, and only newly plucked leaves have the power to attract and stick to identical or virtually identical leaves ,then it has a markedly different property. Of course, the analogy is atrotious because leaves fall from trees all the time, and do not have any abilit to selectively attract other leaves.

MrMalthus wrote:

This is also what Bryson argued:

Judge Bryson wrote:

Neither isolation of the naturally occurring material nor the resulting breaking of covalent bonds makes the claimed molecules patentable. We have previously stated that “isolation of interesting compounds is a mainstay of the chemist’s art,” and that “[i]f it is known how to perform such an isolation doing so ‘is likely the product not of innovation but of ordinary skill and common sense.’” Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1302 (Fed. Cir. 2007), quoting KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007). Similarly, the structural changes ancillary to the isolation of the gene do not render these claims patentable. The cleaving of covalent bonds incident to isolation is itself not inventive, and the fact that the cleaved molecules have terminal groups that differ from the naturally occurring nucleotide sequences does nothing to add any inventive character to the claimed molecules. The functional portion of the composition—the nucleotide sequence—remains identical to that of the naturally occurring gene.

The only thing I can say is that Judge Bryson went completely off the rails here. Both the Supreme Court and the Federal Circuit have repeatedly emphasized that you may only consider the claimed invention as a whole -- it is improper to break the invention down into individual components or differences and then look only to whether those individual parts are inventive. The statement that "the cleaved molecules have terminal groups that differ... does nothing to add any inventive character" is both factually false and wildly off-topic. It is factually false because of the cDNA binding characteristic I keep discussing. It is wildly off-topic because the question is whether the molecules are statutory subject matter (35 USC 101) as a composition of matter that is not a product of nature -- not whether the molecules are nonobvious variants of a product of nature (35 USC 103).

MrMalthus wrote:

DRJlaw wrote:

Myriad and its partners did that, and appear to have done it first. Now you want to argue that they didn't do anything, and that what they did was "standard." Too bad the courts aren't buying it.

This part is just incorrect. Go look at the case. This is actually one of the key arguments of the plaintiffs and in the US only the majority of the Federal Circuit "aren't buying" *all* parts of that argument, hinging solely on use of the word "isolated" in the patent claims, while still striking down virtually all of Myriad's diagnostic claims.

This could very well go Myriad's way (though the Supreme Court seems to think that Bilski and Prometheus v. Mayo apply much more here than the federal circuit does), but please stop suggesting that your opinion happens to also be settled law.

Please stop suggesting that either Bilski or Prometheus apply to products of nature rather than the abstract ideas exception. Please stop suggesting that I have had anything to say about the method claims. Please stop suggesting that I have suggested that my opinion is settled law -- show me where I have argued anything other than a position or a probability.

The courts aren't buying it. The plaintiffs lost at in the Federal Circuit twice. Commenting on that is not saying that a matter which has been granted cert is settled law, but it certainly gives appropriate weight to the dissenting position, which is not the law until adopted by the Federal Circuit en banc or the Supreme Court.

You seem to disregard facts in the real world that do not agree with your viewpoint. Show me where the claimed molecule exists. Because even the government agrees that it does not exist within a living cell.

They were not decoding any message, or coming up with any new message. They were developing a small molecule which chemically binds to a particular gene. That small molecule does not occur in nature. Merely saying that claims to the contrary are "patently false" does not make it so. Show me where the claimed molecule exists.

What you describe in the bold part is the diagnostic test. Whether such a molecule is patentable probably depends on whether the construction is obvious, given that you know the gene you are trying to bind. Whether or not the construction is obvious is no doubt a contentious issue.

However, the bigger controversy is that they did not just patent the diagnostic test, they patented the gene itself. Hence, even if it were possible to develop an entirely different small molecule that binds to the gene, you would still be violating the patent. This Ars article, from the title till the end, as well as the comments, including the material quoted by yourself, all refer to patenting the gene itself, not to the diagnostic test. The gene is the sequence of base pairs that encodes (or, when mutated, fails to encode) the construction of a particular protein. The sequences that they patented are small sections of the DNA sequences found in humans. Determining which part of the whole DNA sequence was relevant was a worthy scientific discovery, but not an invention: the sequence already existed.

I assume you're a lawyer. This sort of playing around with the technicalities of the law is rather annoying and counterproductive to our society.

"Technicalities of the law" such whether that addition to your house complies with the building code, whether the radar gun that clocked you at 63 mph in a 60 mph zone really was calibrated properly or reading 5 mph fast, or whether you actually qualify for social security disability.

It's amazing how standards become "technicalities" when they run counter to your preferred outcome. You draw a line, and then try to retroactively redraw it when something falls on one side in a way that you don't like.

When the letter of the law becomes more important than the concept the law is supposed to represent, yes, they are technicalities.

I assume you're a lawyer. This sort of playing around with the technicalities of the law is rather annoying and counterproductive to our society.

"Technicalities of the law" such whether that addition to your house complies with the building code, whether the radar gun that clocked you at 63 mph in a 60 mph zone really was calibrated properly or reading 5 mph fast, or whether you actually qualify for social security disability.

It's amazing how standards become "technicalities" when they run counter to your preferred outcome. You draw a line, and then try to retroactively redraw it when something falls on one side in a way that you don't like.

When the letter of the law becomes more important than the concept the law is supposed to represent, yes, they are technicalities.

So who defines the concept the law is supposed to represent? Better yet, how do they represent that concept to others other than by words?

Apparently I can settle this by saying the law is supposed to include the concept. Done.

You seem to disregard facts in the real world that do not agree with your viewpoint. Show me where the claimed molecule exists. Because even the government agrees that it does not exist within a living cell.

They were not decoding any message, or coming up with any new message. They were developing a small molecule which chemically binds to a particular gene. That small molecule does not occur in nature. Merely saying that claims to the contrary are "patently false" does not make it so. Show me where the claimed molecule exists.

What you describe in the bold part is the diagnostic test. Whether such a molecule is patentable probably depends on whether the construction is obvious, given that you know the gene you are trying to bind. Whether or not the construction is obvious is no doubt a contentious issue.

I see no basis for granting foreknowledge of the sequence as a given.

Fearknot wrote:

However, the bigger controversy is that they did not just patent the diagnostic test, they patented the gene itself. Hence, even if it were possible to develop an entirely different small molecule that binds to the gene, you would still be violating the patent. This Ars article, from the title till the end, as well as the comments, including the material quoted by yourself, all refer to patenting the gene itself, not to the diagnostic test. The gene is the sequence of base pairs that encodes (or, when mutated, fails to encode) the construction of a particular protein. The sequences that they patented are small sections of the DNA sequences found in humans. Determining which part of the whole DNA sequence was relevant was a worthy scientific discovery, but not an invention: the sequence already existed.

But the molecules did not. In addition, I defy you to find a claim to "the gene." Loosely written articles and comments do not define what is claimed. The claims in the patents define what was claimed.

If you created an entirely different small molecule that binds the gene, it would not violate the patents, because the patent claims are first to isolated DNA and RNA molecules reflecting only the structure of that gene, then to structures or genetic vectors building from those isolated molecules. For example:

"An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2."

Create a protein which binds to "the gene," no infringment. Create an enzyme which binds to "the gene," no infringement. Design other molecules to interact with "the gene" based only upon the information of the gene -- AATACG.... -- no infringement. Work with mixtures of DNA merely including the gene... no infringment. When you reduce it to "they patented the gene..." you get the idiocy of fferitt25, where suddenly Myraid has allegedly patented "the gene" in vivo in human beings.

MrMalthus suggests that merely sequencing the BRCA genes can infringe. Show me the claim which reads on any sequencing process, much less HGP-type sequencing processes. You won't find it. Nobody (except perhaps Craig Venter, who published in 1997) anticipated shotgun sequencing in 1995. That's why Venter is rather wealthy these days.